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TOPIC: Kerastem reports successful Alopecia phase 2 trials

Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 09:06 #10722

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Can be found on Cytori Facebookl.

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 09:54 #10723

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Franshei, the market cap and SP have reached the level of absurdity - one can only believe that this may be what Tiago/Hedrick want for employee stock option pricing in early January (and why their participation in the RO along with other employees was meager) - DISGRACEFUL and I informed Tiago of my feelings and I believe that they should get no options in 2018 - however for me, if it looked good for purchase at .33 (albeit with the warrants), it is still looking very attractive for purchase at .25!

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 09:56 #10724

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Very nice! :nice:



SAN DIEGO, Dec. 7, 2017 /PRNewswire/ -- Kerastem reports 6-month top-line data from its clinical study STYLE, a 70 patient, phase II, US multi-center, randomized, single-blinded, and controlled clinical trial investigating Kerastem's therapy in patients with early stage hair loss. The Kerastem therapy is a one-time treatment that utilizes adipose (fat) derived regenerative cells combined with purified fat delivered to the affected area of scalp.

Low dose Adipose Derived Regenerative Cells (ADRC's) + Puregraft fat treatment group achieved a statistically significant increase in mean terminal hair count, when compared to control, in males with early stage hair loss (Norwood Grades I-III). An average increase of 29 terminal hairs per cm2 of scalp was observed, corresponding to a 17% increase (p < 0.05) from baseline.
All treatment arms of STYLE were safe with no serious adverse events reported.
"The Kerastem team has successfully identified a treatment that stimulates hair growth in people with early stage hair loss," stated Brad Conlan, CEO of Kerastem. "There are over 40 million people with early stage hair loss in the United States alone. Kerastem is poised to disrupt this market based upon the results from STYLE and is actively signing and exploring distribution relationships outside of the United States. We are thrilled about the STYLE data and what it means for patients with early stage hair loss who have had very few treatment options to date."

KERASTEM SUPERIOR TO OTHER CELL BASED TREATMENT CURRENTLY AVAILABLE

According to Dr. Eric Daniels, Kerastem's Chief Medical Officer, "STYLE indicates that dosing and tissue preparation are essential to achieving a successful outcome. Added Dr. Daniels, "We were very pleased to see the positive results from the low dose arm and were surprised that the high dose ADRC's + Puregraft fat treatment group, along with the fat alone group, observed a reduction, or no change, respectively in terminal hair counts. Stated otherwise, dosing and tissue purity matter."

To understand the STYLE results in context--the low dose treatment group had an average increase of 29 hairs per cm2 of scalp, which corresponds to an increase of 2,900 hairs per 100 cm2 of treated scalp. While the average hair transplant today is between 1,900 to 2,200 transplanted hairs, patients with early hair loss are very often not candidates for hair transplantation. Kerastem therapy represents a new option. The therapy utilizes patented medical device technology to deliver a consistent cell therapy output, enabling appropriate dosing.

ANDROGENETIC ALOPECIA MARKET SIZE

Hair loss affects more than 40 million men and 21 million women and in the United States alone. The global hair loss treatment market generates more than $7 Billion annually and currently has limited options for men (grades I-III) and women (grades I-II) with early stage hair loss.

ABOUT KERASTEM

Kerastem is the leader in the development and commercialization of cell-based approaches to hair growth. The company is a wholly owned subsidiary of Bimini Technologies. The Bimini portfolio also includes Puregraft, the world's leading fat transfer solution.

Link- HERE

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 10:08 #10725

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Rodney

As you know, it would take a few days for this news be known. Maybe there will be some action next Tuesday.

I am glad you have aired your frustration to Tiago Hedrick and M Hedrick. As usuall the reply is "we understand your frustration" or " we can understand that you are upset" or "we are working hard to bring out stockholders' value" or "just hold tight, we are working hard"......

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 10:18 #10726

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“it is still looking very attractive for purchase at .25!”

It will look even better at 0.20 or lower. Hedge is right, it’s probably heading for another RS.

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 10:18 #10727

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franshei wrote: Rodney

As you know, it would take a few days for this news be known. Maybe there will be some action next Tuesday.

I am glad you have aired your frustration to Tiago Hedrick and M Hedrick. As usuall the reply is "we understand your frustration" or " we can understand that you are upset" or "we are working hard to bring out stockholders' value" or "just hold tight, we are working hard"......


Franshei, I am not looking for a significant impact from this news.

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 10:21 #10728

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Rodney
Re Cytori Nanomedicine, the company can actually talk talk to somepotential partners now. The APHA bioavailabity data and AZA inhouse stability data (on file and this has been mentioned by Hedrick) can get the ball rolling. By the end of 2017, CYTX should have complete the manufacturing scaling up - maybe this this is the step to precipitate more action in the partnership talk. By mid 2018, the company should have 6 month stability data for EU submission.

The liposomal taxo strategy is efficacy equivalency vs taxol with lower incidence of myelosuppression.

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 11:03 #10729

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b767cpt wrote: “it is still looking very attractive for purchase at .25!”

It will look even better at 0.20 or lower. Hedge is right, it’s probably heading for another RS.


Don't bet on it - appears that perhaps you have sold!

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 11:04 #10730

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franshei wrote: Rodney
Re Cytori Nanomedicine, the company can actually talk talk to somepotential partners now. The APHA bioavailabity data and AZA inhouse stability data (on file and this has been mentioned by Hedrick) can get the ball rolling. By the end of 2017, CYTX should have complete the manufacturing scaling up - maybe this this is the step to precipitate more action in the partnership talk. By mid 2018, the company should have 6 month stability data for EU submission.

The liposomal taxo strategy is efficacy equivalency vs taxol with lower incidence of myelosuppression.



Franshei, you do not have to convince me - I am a buyer at these prices!

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 12:45 #10731

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“appears that perhaps you have sold!”

Nope, and I’ll be looking to average down some more when it hits 0.20, perhaps at the current but I’m still thinking it will go lower before turning around.

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 13:32 #10732

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b767cpt wrote: “appears that perhaps you have sold!”

Nope, and I’ll be looking to average down some more when it hits 0.20, perhaps at the current but I’m still thinking it will go lower before turning around.


I continue to consider the stock a great buy at .25 and .20 is even better, but it's not going to happen imo - who will be selling at those levels when the RO was over-subscribed at .33 and anyone shorting this at these levels or lower is nuts even if they turn out to be right in a few years - even the decline to .25 makes no sense to me other than for the devious achievement of providing for lower priced stock option grants in Jan. - we may be witnessing another bout of the big M!

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 14:19 #10733

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Interesting that only the low dose showed anything. Fat graft didn't help at all. But since this is a treatment for early baldness, if a limited area is treated successfully, wouldn't one expect male pattern baldness to continue for the rest of the scalp? Seems like it would require multiple treatments. 6 months is a reasonable time frame but I'd be curious if this holds up at 12 months. Still a long way to revenues on this, IMHO.

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Kerastem reports successful Alopecia phase 2 trials 07 Dec 2017 14:38 #10734

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Good question on the durability factor WST !
The reason hair transplant works is that the hairs harvested have been resistant (for lack of a better word) to the ravages that cause male pattern baldness.
Pictures in the past that Cytori had been showing wernt all that impressive but who know if it catches on or not.
Agree, still some time away.

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Kerastem reports successful Alopecia phase 2 trials 08 Dec 2017 08:07 #10736

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Karestem's phase 2 success has good implications: potentially it may enhance cYtori's sales (even if Karestem continues self paid protocol treatment, without going through"higher risk" and complicated phase 3 ).

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Kerastem reports successful Alopecia phase 2 trials 08 Dec 2017 08:52 #10737

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franshei, current regulations as I understand them would require FDA approval just like any other procedure that uses an enzyme to more than minimally manipulate the cells to sperate them from their natural environment, i.e., adipose.

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